PMA P200029S008
- Device
- TheraSphereTM Y-90 Glass Microspheres System
- Applicant
- Boston Scientific Corporation
- PMA number
- P200029
- Supplement
- S008
- Product code
- NAW
- Decision date
- 2024-02-07
- Classification
- Radiology
- Generic name
- Microspheres radionuclide
- Approval order statement
- approval to implement ISO 80369 compliant luers in the TheraSphere Administration Sets manufactured by CEA Medical Manufacturing (CEA)
Current openFDA PMA Record#
- Device
- TheraSphereTM Y-90 Glass Microspheres System
- Applicant
- Boston Scientific Corporation
- PMA number
- P200029
- Supplement
- S008
- Product code
- NAW
- Generic name
- Microspheres radionuclide
- Decision date
- 2024-02-07
- Decision code
- OK30
- Date received
- 2024-01-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval to implement ISO 80369 compliant luers in the TheraSphere Administration Sets manufactured by CEA Medical Manufacturing (CEA)